Product code MTD
- Device name
- Catheter, Intracardiac Mapping, High-Density Array
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1220
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | 2026-04-23 |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | 2026-03-13 |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024-08-07 |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2024-07-09 |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster, Inc. | 2023-07-10 |
| K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | 2023-03-17 |
| K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | Biosense Webster, Inc. | 2023-03-02 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | 2022-06-21 |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2022-03-18 |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2020-09-15 |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2020-09-03 |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020-08-06 |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | 2020-07-31 |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018-04-23 |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2017-10-16 |
| K163709 | FIRMap Catheter | Abbott Electrophysiology | 2017-02-28 |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | 2016-04-07 |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | 2014-09-09 |
| K140733 | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | Boston Scientific Corporation | 2014-04-28 |
| K130827 | FIRMAP CATHETER | Topera, Inc. | 2013-10-31 |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2013-03-05 |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2012-05-24 |
| K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER | St Jude Medical | 2012-05-03 |
| K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) | Biosense Webster, Inc. | 2005-03-30 |
| K021232 | CONSTELLATION CATHETERS, MODEL 8031M | Boston Scientific Corp | 2002-05-16 |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Endocardial Solutions, Inc. | 2001-09-28 |
| K003782 | CONSTELLATION CATHETER, MODEL 8031 | Boston Scientific Corp | 2001-02-14 |
| K000277 | CONSTELLATION CATHETERS | Boston Scientific Corp | 2000-09-26 |
| K992777 | CONSTELLATION CATHETERS, MODEL 8039 | Boston Scientific Corp | 1999-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850064686166 | OptiMap Catheter - 60mm | Cortex, Inc. | 2026-05-15 |
| 00850064686159 | OptiMap Catheter - 50mm | Cortex, Inc. | 2026-04-02 |
| 00850064686067 | OptiMap™ Catheter - 50mm | Cortex, Inc. | 2025-07-24 |
| 00850064686074 | OptiMap™ Catheter - 60mm | Cortex, Inc. | 2025-07-10 |
| 05415067049889 | Advisor™ HD Grid X, Sensor Enabled™ | ST. JUDE MEDICAL, INC. | 2024-08-23 |
| 00841824105560 | ECOII | W.H.P.M. INC. | 2024-08-22 |
| 00860457001551 | Ablacon™ Mapping Catheter | Ablacon Inc. | 2023-12-07 |
| 00860457001544 | Ablacon™ Mapping Catheter | Ablacon Inc. | 2023-12-07 |
| 10846835025828 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster Inc | 2023-10-04 |
| 10846835025811 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster Inc | 2023-10-04 |
| 10846835021158 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10846835021110 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10846835021127 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10846835021134 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10846835021141 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10846835021233 | OCTARAY Mapping Catheter | Biosense Webster Inc | 2021-10-14 |
| 10888551045209 | NA | STERILMED, INC. | 2021-10-12 |
| 10888551045179 | NA | STERILMED, INC. | 2021-10-12 |
| 10888551045186 | NA | STERILMED, INC. | 2021-10-12 |
| 10888551045193 | NA | STERILMED, INC. | 2021-10-12 |
| 00857042007401 | AcQMap | ACUTUS MEDICAL, INC. | 2021-10-08 |
| 00857042007418 | AcQMap | ACUTUS MEDICAL, INC. | 2021-10-08 |
| 10846835022056 | CARTO 3 System eco Interface Cable | Biosense Webster Inc | 2021-07-30 |
| 05415067028198 | Advisor™ HD Grid, Sensor Enabled™ | ST. JUDE MEDICAL, INC. | 2018-05-01 |
| 08714729780472 | Constellation® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729780465 | Constellation® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729780458 | Constellation® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729780441 | Constellation® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729780434 | Constellation® | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10846835009576 | PENTARAY NAV | Biosense Webster Inc | 2016-09-16 |